Basic Information
Zenhale Pressurized Inhalation Aerosol 50/5mcg/actuation
AEROSOL, METERED
Regulatory Information
SIN14189P
July 11, 2012
Prescription Only
Therapeutic
RESPIRATORY (INHALATION)
August 10, 2023
May 30, 2025
XR03AK07
Company Information
Active Ingredients
Strength: 0.0605mg
Strength: 0.0061mg
Detailed Information
Contraindications
**5.1 Contraindications** Patients with known hypersensitivity to mometasone furoate, formoterol fumarate or to any of the excipients.
Indication Information
**4.1 Therapeutic Indications** **ZENHALE**, administered twice daily, is indicated for the maintenance treatment of asthma, in adults and children 12 years of age and older with reversible obstructive airway disease, whose asthma cannot be adequately controlled on asthma controller medications. **ZENHALE** is not indicated for patients whose asthma can be managed by occasional use of a rapid onset, short duration, inhaled beta2-agonist or for patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of a rapid onset, short duration, inhaled beta2-agonist. **ZENHALE** should be used for patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta2-agonists or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. **ZENHALE** may also be used in patients already adequately controlled on both inhaled corticosteroid and long-acting beta2-agonist. **ZENHALE** contains a long-acting beta2-agonist and should not be used as a rescue medication. To relieve acute asthmatic symptoms, a rapid onset, short duration inhaled bronchodilator (e.g., salbutamol) should be used. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue **ZENHALE**) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use **ZENHALE** for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.